Corporeal Drainage System

ABSTRACT

A corporeal drainage system and a method of draining fluid from a bodily cavity. The corporeal drainage system includes a connection tube and a fluid receptacle in fluid communication with the connection tube. The fluid receptacle creates a negative pressure in the system by transitioning from a collapsed configuration to an expanded configuration. The system may include an activation member to initiate transitioning of the fluid receptacle.

PRIORITY

This application is a division of U.S. patent application Ser. No.13/688,000, filed Nov. 28, 2012, now U.S. Pat. No. 8,814,839, which is adivision of U.S. patent application Ser. No. 11/248,082, filed Oct. 12,2005, now U.S. Pat. No. 8,337,475, which claims the benefit under 35U.S.C. §119(e) of U.S. Provisional Application No. 60/617,758, filedOct. 12, 2004, each of which is expressly incorporated by reference asif fully set forth herein.

BACKGROUND OF THE INVENTION

Fluid accumulation due to sickness or trauma may develop in areas withina mammalian body not designed to accommodate such accumulation. Oneparticular area prone to abnormal accumulation is between sheets oftissue covering the outside of the lung and lining the chest cavity,known as the pleural space. While a normal functioning pleural spacecontains approximately 5-20 mL of fluid, fluid turnover occurs on anhourly basis such that approximately 5-10 L of fluid passes through thepleural space every day. Thus, any disruption in fluid turnover mayresult in over-accumulation of fluid in the pleural space, known aspleural effusion. The symptoms of pleural effusion include dyspnea,tachycardia, cough, breathing difficulty and chest pain as the lungs areprevented from fully expanding upon breathing. Pleural effusion is acondition secondary to trauma, cancer, nephrotic syndrome, kidneydisease, pancreatitis, congestive heart failure and cirrhosis, and assuch, patients affected with pleural effusion will usually die withinthree months of onset. Consequently, treatment of pleural effusion isgenerally provided for patient quality of life in his/her final days.

There are numerous methods to treat pleural effusion and/or otherunwanted fluid accumulation in a mammalian body. Fluid drainageprocedures, such as thoracentesis, may be used to provide patientrelief. Thoracentesis involves the introduction of a needled catheterinto the pleural space through an incision in the chest cavity, afterwhich fluid is drawn out using a syringe or a vacuum source. Drawbackswith this procedure, however, include the fact that the needle mayinadvertently puncture a lung, leading to aggravation of the problem,and the fact that fluid readily re-accumulates in the pleural spaceafter the procedure is performed such that it may become necessary for apatient to undergo the procedure every few days. Pleurodesis is aprocedure in which fluid is prevented from accumulating due to thesealing of the space between pleura with either sterile talc or anantibiotic, after first draining the existing fluid. Another method totreat pleural effusion is to surgically implant a chest tube or cathetersuch that fluid accumulation can constantly or periodically be removedwithout invasive surgery. The implanted catheter may be connected to anexternal catheter or drainage tube by a one-way valve mechanism, whichpermits fluid drainage through the use of a negative pressure source,such as a vacuum. One example of such a catheter system is described inU.S. Pat. No. 5,484,401 to Rodriguez et al., which is expresslyincorporated by reference as if fully set forth herein.

While catheter-based systems have been described in the prior art, andindeed are being utilized by patients in the US, significant drawbacksexist. For example, although effective and clinically acceptable,existing catheter-based systems suffer from one or more of the followingdeficiencies: 1) the catheter/drainage tube connection is not secure andcan be easily pulled apart (while not life threatening, accidentaldisconnection will cause loss of vacuum pressure mandating set-up with anew system; also, such disconnects can be the cause of pleural orperitoneal infection); 2) the clamp supplied on the drainage tube isdifficult to use and is not an effective means of controlling fluidflow; 3) the system is useless in the event of an accidental loss ofvacuum (effective safety mechanisms designed to prevent such accidentalor premature loss of vacuum are missing); 4) the clamp sealing thevacuum chamber (which must be removed in order to activate drainage) isdifficult for older patients and care givers to detach; 5) thecollection chambers provided with the drainage systems (typically 500mL) are not adequately sized for peritoneal drainage where fluidcollection volumes can reach 2000 mL.

Thus, there is a need for an improved system for corporeal drainage,which will provide beneficial aspects, including those that willfacilitate the use thereof regardless of patient location or condition.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a corporeal drainage system, showing acontainer in an open position for positioning of a disposable fluidcollection bag.

FIG. 2 is a perspective view of the corporeal drainage system of FIG. 1,showing the container in a semi-closed position.

FIG. 3 is a perspective view of the corporeal drainage system of FIG. 1,showing the container in a closed position.

FIG. 4 is a bottom perspective view of another embodiment of a corporealdrainage system, showing in phantom a latch tab and latch clasp. Thefluid receptacle is shown in an expanded state.

FIG. 5 is a top perspective view of the corporeal drainage system ofFIG. 4.

FIG. 6 is a top perspective view of the corporeal drainage system ofFIG. 4, shown in a collapsed state in which the latch tab is connectedto the latch clasp.

FIG. 7 is a side plan view of another embodiment of a corporeal drainagesystem, showing a fluid receptacle in the form of a bottle in anexpanded state.

FIG. 8 is a side plan view of the corporeal drainage system of FIG. 7,showing the bottle in a collapsed state.

FIG. 9 is a perspective view of the corporeal drainage system of FIG. 8,showing a distal end of a connection tube inserted into a containerholding an amount of fluid to simulate the drainage of a bodily cavity.

FIG. 10 is a perspective view of the corporeal drainage system of FIG.9, following expansion of the bottle and transfer of the fluid from thecontainer into the bottle.

FIGS. 11-13 are perspective views of the corporeal drainage system ofFIGS. 9-10, illustrating a passive siphoning process.

FIG. 14 is a side plan view of a fluid receptacle for use with acorporeal drainage system, in which the fluid receptacle also isconfigured to initiate a negative pressure in the system.

FIG. 15 is a longitudinal cross-sectional view of the fluid receptacleof FIG. 14 in a collapsed state.

FIG. 16 is a longitudinal cross-sectional view of the fluid receptacleof FIG. 14 in an expanded state.

FIGS. 17A-C illustrate a hand pump for use with a corporeal drainagesystem, the pumps in the figures all having a bulbous configuration.

FIG. 18 is another embodiment of a hand pump for use with a corporealdrainage system, the hand pump having a tubular configuration.

FIG. 19 is one embodiment of a corporeal drainage system, incorporatingthe hand pump of FIG. 18.

FIG. 20 is one embodiment of a corporeal drainage system, illustrating aconnection system between an implanted catheter and a fluid flowconduit.

FIGS. 21-26 illustrate various examples of connection systems for usewith a corporeal drainage system.

BRIEF SUMMARY OF THE INVENTION

Accordingly, a corporeal drainage system is described herein thatprovides beneficial aspects to a target user. In one aspect of theinvention, a corporeal drainage system utilizes an inline pump thatconnects to both the implanted catheter and drainage tube viaunidirectional check valves. In another aspect, an inline drip chamberis provided for a corporeal drainage system to monitoring drainage froma bodily cavity. In one embodiment, the inline pump made of atransparent material such that it serves the dual purpose of providingboth an inline pump and a drip chamber.

In another aspect of the invention, a corporeal drainage system isconfigured for use as a passive siphoning system, in which a negativepressure is created following initial activation, in order to alleviatework required by a user in operating the system. In one embodiment,following initial activation (e.g., pump is primed, collapsiblecontainer is initially expanded from a collapsed state, etc.), thesystem is positioned at a level below the reservoir or cavity to bedrained to create a siphon system where the weight of the fluid in thetubing acts to drag fluid out of the elevated reservoir. In anotheraspect of the invention, a corporeal drainage system includes asemi-reusable collection system having a multiple use outer rigidcontainer with single use disposable inner plastic collection bag linersthat has the capacity to reactivate the required vacuum for use. Instill another aspect of the invention, a corporeal drainage system isconfigured as a single use, low cost collection system with a pre-loadedforce, in which the fluid receptacle also acts as a catalyst forproducing a negative pressure in the system. In one embodiment thecollection system includes a bottle that is locked in a collapsed statefor shipping and storing and can be activated by unlocking. In anotherembodiment, the collection system includes a disposable bag that can beprimed or activated to produce a negative pressure, while also servingas a fluid receptacle.

In another aspect of the invention, a corporeal drainage system isprovided such that an implanted catheter can be securely connected to anexternal fluid flow conduit with minimal effort through use of aconvenient connection system. In one embodiment, the connection systemincludes a catheter connector that can be connected to a drainage lineconnector.

In one embodiment, a corporeal drainage system includes an implantablecatheter, a connection tube, a connection system, including a catheterconnector attached to a proximal end of the catheter and a drainage lineconnector attached to a distal end of the connection tube, and a pump,including a first unidirectional check valve and a second unidirectionalcheck valve, wherein the first unidirectional check valve is positionedat one end of the pump to connect the pump to the fluid receptacle andthe second unidirectional check valve is positioned at an opposite endof the pump to connect the pump to the connection tube.

In another embodiment, a corporeal drainage system includes a catheterincluding a catheter connector at a proximal end thereof, a connectiontube including a drainage line connector at a distal end thereof, thedrainage line connector and catheter connector being configured forsealing attachment to one another, and a disposable fluid receptacle influid communication with the connection tube, the fluid receptacle beingconfigured to create a negative pressure within the system uponactivation thereof.

A method of draining fluid from a bodily cavity using a corporealdrainage system having a fluid receptacle includes attaching aconnection tube to the proximal end of an implanted catheter, initiatinga negative pressure in the system such that fluid flows from the bodilycavity in a direction toward the proximal end of the catheter, andplacing the fluid receptacle at a level below the bodily cavity.

These and other objectives, embodiments, features and advantages of thepresent invention will become more apparent to those skilled in the artwhen taken with reference to the following more detailed description ofthe invention.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description illustrates by way of example, not by way oflimitation, the principles of the invention. This description willclearly enable one skilled in the art to make and use the invention, anddescribes several embodiments, adaptations, variations, alternatives anduses of the invention, including what is presently believed to be thebest mode of carrying out the invention.

The embodiments described herein are directed to a corporeal drainagesystem designed to effectively provide a user the ability to drain fluidfrom their body in a non-clinical setting with a minimum amount ofeffort. The embodiments of the invention generally contain a connectiontube having a proximal end that is either detachably or permanentlyconnected to a pump or container and a distal end that is fashioned witha connector device that permits quick, easy and secure attachment to adevice or mechanism inserted within a bodily cavity, including, forexample, an indwelling device such as an implanted catheter or port. Theconnector device may be a standard luer connector or other likeconnectors as known to one skilled in the art. For example, if animplanted catheter has at its proximal end a female needleless injectionport, the connection tube can have at its distal end a male luerconnector. Particular connection systems to sealingly connect animplanted catheter to a fluid flow conduit in a corporeal drainagesystem are disclosed in commonly owned U.S. Provisional Application No.60/720,443, filed Sep. 26, 2005, entitled “Catheter Connection System,”the complete contents of which are expressly incorporated by referenceas if fully set forth herein.

The connection tube may be made of polyurethane or other material knownto one skilled in the art suitable for a bodily fluid conduit. Theconnection tube should be of sufficient length to accommodate all users,such that the container may be placed on the ground or at a locationbeneath the cavity to be drained without undue discomfort. If the systemis configured with a connection tube that is detachable from thecontainer, different lengths can be provided by the treating cliniciandepending on height of the user and/or other parameters, such as likelylocation for the draining operation, length of the catheter extendingoutside of the patient's body, etc. Currently, the standard contemplatedlength of the connection tube is in the range of approximately 3 ft to 5ft. The implanted catheter may be any standard medical catheter suitablefor insertion into a bodily cavity, having at its proximal end aconnector that attachably cooperates with the connector device attachedto the connection tube (e.g., male or female luer connector). Forexample, suitable catheters include peritoneal catheters, thoracicdrainage catheters, etc. Moreover, in the embodiments of the invention,a fluid receptacle, which may take the form, for example, of acontainer, disposable bottle and/or disposable bag can holdapproximately 1 L of fluid, although certainly a wide range of volumecapability is contemplated for the fluid receptacles of the presentinvention (e.g., in the range of approximately 0.5 L to 5 L).

Referring now to FIGS. 1-3, a corporeal drainage system 10 includes avacuum pump 12, a vacuum box/container 14, a drainage bag 16 and aconnection tube 30. The connection tube 30 is as described above. Thevacuum pump 12 may include a flexible membrane 20 and a pair of one-waycheck valves 22 (FIG. 3) and can be fashioned in various shapes andsizes. The one-way check valves 22, 24, may be any type ofunidirectional flow valve as is well-known to one skilled in the art.The vacuum pump 12 is operatively associated with the container via afirst one-way check valve 22, which permits evacuation of air whilemaintaining a vacuum as it is created within the system 10. Inparticular, the first one-way check valve 22, permitting movement of airfrom the container, connects the vacuum pump 12 to the container 14. Asecond one-way check valve 24, positioned on the vacuum pump 12, permitsrelease of air from the pump 12. Thus, creation of a negative pressurein the system 10 includes first activating the pump 12 throughcompression thereof (e.g., pressing downward on the flexible membrane20), which evacuates the air inside the vacuum pump 12 through thesecond check valve 24 positioned on the pump 12, and second releasingthe pump 12 (e.g., removing the applied pressure from the flexiblemembrane 20), which permits expansion thereof by pulling air from thecontainer 14 through the first check valve 22.

The vacuum pressure provided to the system 10 is dependent on a numberof factors, such as, for example, the number of times the pump 12 isactivated (e.g., the number of times pressure is applied to the flexiblemembrane 20 and subsequently released), which can be varied based on thetype of material used and the surface area of the pump 12 (rebound forceof the pump (F)/surface area (A)=pressure (P)). Literature suggests thata negative pressure of approximately 30 mm Hg is the maximum that mostbodily cavities in mammals are capable of withstanding. Thus, with sucha relatively small amount of pressure demanded for the system, thevolume of the pump and the material choice for the pump, including wallthickness and durometer, must be carefully considered so that a balanceis struck between the number of pumps needed and amount of forcenecessary for a single activation of the pump. Such selection of wallthickness and durometer will also permit one to control the negativepressure placed into the system, which can be limited to provide asafety function (i.e., the amount of negative pressure possible can belimited by material selection such that even if the maximum amount wasachieved by the user, said amount would not exceed the maximumpermissible for the bodily cavity to be drained). Given the fact thatsystem 10, and other systems described herein, will likely be used bypatients with diminished strength and energy, these considerations canplay an important role in the design of the system. In an exemplaryembodiment, the flexible membrane 20 of pump 12 is made of 55 Shore Apolyvinylchloride with a wall thickness in the range of approximately0.05 in to approximately 0.5 in.

In order to maintain a consistent flow of fluid from the bodily cavityin prior art systems, the pump needs to be activated at leastintermittently by the user. As previously mentioned, however, the targetuser may be unable or unwilling to do so. Thus, an advantage of thesystem described herein is that it is designed with the ability to actas a siphon after initial activation. Specifically, once the user hasactivated the pump a few times (e.g., in the system 10 described above,when the user has collapsed the flexible membrane 20 and subsequentlyallowed air from the system to re-expand it two or more times), the usermay then place the container (e.g., container 14) on the ground (or anylocation below the body cavity from which drainage is taking place),which effectively creates a passive siphon system that utilizes theweight of the fluid within the catheter and/or connection tube 30 topull fluid out of the bodily cavity (elevated reservoir). This abilityto create a passive system requires only minimal effort from the user,which allows the system to be used in a non-clinical setting by a widerange of users, regardless of physical condition.

The vacuum box/container 14, while illustrated in a rectangular boxform, may take on virtually any shape. The container 14 may include alid 18 that is hinged to a body, as shown in FIGS. 1-3, in order tosimplify the removal and installation of a disposable bag 16, althoughmany configurations without a hinged lid 18 are also possible and withinthe scope of the invention as would be apparent to one skilled in theart. Due to the configuration of the system 10 that includes adisposable bag 16, the system can be used numerous times. An apertureconfigured for passage of the connection tube 30 is positioned on a sideof the container, having associated with it a grommet 26 made of amaterial, such as silicone rubber, to provide a sealing function for theaperture. In one embodiment, the container also has a gasket positionedaround the lid or disposable bag opening such that when said lid oropening is closed, an enhanced seal is provided. The connection tube 30is detachable from the container 14 in one embodiment to facilitatecleaning of the container 14 (see FIG. 1). In other embodiments, theconnection tube 30 is permanently connected to the container 14. Thecontainer 14 may be made of a rigid plastic material, although manyother rigid materials are also suitable, such as, for example,polycarbonate, high density polypropylene, nylon, Lexan®, stainlesssteel, etc. In the event that the system is designed to be reusable,such as the embodiment shown in FIGS. 1-3, the material choice should beone that may be readily cleaned (e.g., dishwasher safe).

FIGS. 4-6 illustrate another embodiment of a corporeal drainage system40, including a disposable bottle 42 made of a material, such as a clearrubber or other elastomer, that serves the dual purpose of acting bothas a fluid receptacle and a catalyst or initiator for producing anegative pressure in the system. The term “bottle” as used herein meansany type of container that can be filled with fluid, at least a portionof which can be collapsed, at least in part, to evacuate air therefrom.The bottle 42 in FIGS. 4-6 is in the form of a ball, having anactivation knob 44 on the exterior of one end and a latch tab 48 on theinterior of an opposite end. The activation knob 44 is operativelyconnected to a latch clasp 46 positioned adjacent the knob on theinterior of the bottle 42. The bottle 42 may be molded in an openconfiguration and then collapsed for shipping. Upon collapse of thebottle 42, the latch clasp 46 and the latch tab 48 connect to lock thebottle in a collapsed condition, pending activation (e.g., by pressing,turning, etc.) of the activation knob 44. In this collapsed state forshipping, the bottle has a pre-loaded force so that unlocking of thelatch clasp from the latch tab results in activation of the system withminimal physical effort required of the user.

When the user is ready to initiate drainage of a bodily cavity, theconnection tube 30 is attached to an implanted catheter via theconnector 32 (e.g., luer member), or connection system as described incommonly owned U.S. Provisional Application No. 60/720,443, and theactivation knob 44 is activated, unlatching the latch clasp 46 from thelatch tab 48 and permitting the bottle 42 to expand, pulling fluid fromthe bodily cavity in the process. In order to generate sufficient forceto draw the fluid out of the bodily cavity, the wall thickness of thebottle 42 must be carefully considered. In an exemplary embodiment, thebottle 42 is approximately the size of a softball, is made of anelastomeric material, and has a wall thickness in the range ofapproximately 0.05 in. to approximately 0.5 in. In this embodiment, thematerial of the bottle 42 is disposable, such that once the fluid hasbeen extracted from the bodily cavity, the bottle 42 can be disposed of;each use requiring a new bottle. In other embodiments, the bottle 42 mayinclude an opening such that a disposable bag or other fluid-holdingcontainer can be inserted and removed therefrom.

FIGS. 7-13 illustrate another embodiment of a corporeal drainage system,including a bottle. In this embodiment, the bottle 52 of system 50includes rigid sides, including a top section 54, middle section 56 andbase section 58, and flexible connecting walls, including firstconnecting wall 62 positioned between the top section 54 and middlesection 56 and second connecting wall 64 positioned between middlesection 56 and base section 58. The connecting walls 62, 64 areconfigured to collapse within the rigid sides 54, 56, 58 upon activationof the system 50. The top section 54 has a connection member 60, whichis configured to be removably attached to connection tube 30. Both topsection 54 and base section 58 have respective pull tabs 66 and 68attached thereto, the pull tabs functioning to facilitate the expansionof the bottle 52, following collapse, upon initiation of a drainageprocedure. FIG. 7 illustrates the bottle 52 prior to collapse, whileFIG. 8 illustrates the bottle 52 following collapse. As is apparent fromFIG. 8, in this embodiment, the connecting walls 62, 64 collapsesubstantially within the rigid sides 54, 56, 58 to provide a smallprofile for storage and shipping.

FIG. 9 shows bottle 52 in its collapsed form, as shipped and stored,with the connection tube 30 attached to the connection member 60 at oneend with an opposite end inserted into a container 38 with an amount offluid therein, which exemplifies the draining of a bodily cavity. Asdiscussed, the system 50 is activated by pulling on the pull tabs 66, 68to expand the bottle 52, as illustrated in FIG. 10. The expansion of thebottle 52 results in the fluid from the container 38 being suctionedinto the bottle 52. When the bottle is fully expanded, as shown in FIG.10, a suitable amount of suction has been imparted to the system 50 suchthat a majority of fluid from the container 38 is transferred to thebottle 52. The amount of force required to expand the bottle 52 to anexpanded state is dependent on a variety of factors, including thematerial of the bottle, as discussed above. The amount of expansion ofbottle 52 necessary to drain a particular bodily cavity is variable andalso depends on a number of factors, including the amount of fluid to bedrained. FIGS. 9-10 illustrate an active siphoning process, in which thesiphoning or transfer of fluid from the container 38 to the bottle 52 isdirectly attributable to the expansion of the bottle 52 (i.e., thepulling force applied to the pull tabs 66, 68 as they are pulled inopposite directions). However, the transfer of fluid from container 38to bottle 52 can also be accomplished through a passive siphoningprocess, requiring much less force. This alternative method ofsiphoning, for which system 50 is also designed, is explained in moredetail with reference to FIGS. 11-13.

Through experimentation, it was noted that a pulling force ofapproximately 20 lbs was required to fully expand bottle 52, in order todrain fluid from a bodily cavity. Because such a force requirement maybe prohibitive to some users, another method of creating a vacuum wasexplored. It was discovered that an initial pulling force, significantlyless than the 20 lbs necessary to fully expand the bottle 52, acted tobegin the fluid flow through the catheter and connection tube. FIG. 11shows the bottle 52 in its collapsed state, positioned at the same levelas the container 38 with a level of fluid therein. In the experiment,once fluid began to enter the bottle 52, the bottle 52 was dropped tothe floor or at a level below the container 38. FIG. 12 shows the bottle52 after an initial pulling force, less than 20 lbs, has been applied tothe system 50 (i.e., the pull tabs 66, 68 have been pulled in oppositedirections), the bottle 52 being positioned at a level below thecontainer 38. The action of providing an initial pulling force coupledwith the action of dropping the bottle below the container generated asiphon within the system 50, pulling fluid from the container 38 andeventually filling the bottle 52. As the transfer of fluid from thecontainer 38 to the bottle 52 takes place, the bottle 52 continues toexpand until fully expanded as illustrated in FIG. 13.

Thus, the experiment showed that a reduced pulling force, less than theforce required to fully expand bottle 52, could be utilized with similarresults, thereby overcoming the potential problem of requiring a user toprovide a larger pulling force than could be achieved by the user. Itshould be noted that the amount of negative head pressure (i.e., thelevel or distance of a bottle or container positioned below the drainagereservoir (bodily cavity)) controls the fill rate of the bottle andamount of suction acting on the drainage catheter. Therefore, as thebottle expands and increases in weight, fluid flow rate increases. Assuch, in one embodiment, a bottle, such as bottle 52, is hung orotherwise suspended with a weight attached to the base thereof toincrease flow rate. In another embodiment, a bottle is made of a clearmaterial so that, in addition to the audible flow indication, a visualflow indication would be provided to the user.

FIGS. 14-16 illustrate another embodiment of a corporeal drainagesystem. In this embodiment, system 70 includes a disposable bag 72without an associated container, the disposable bag 72 being made of adisposable material so that it serves as a fluid receptacle. Thedisposable bag 72 is also configured such that it can be directlymanipulated (similar to the bottle 52 of FIGS. 7-13) to produce anegative pressure for the purposes of fluid drainage from a bodilycavity. The disposable bag 72 is fashioned with rigid members 74attached to opposing sides of the bag 72, the rigid members 74 havingpull tabs 76 connected thereto. The rigid surface area of the rigidmembers 74 compared to the flexible surface area of the flexible portionof bag 72 is calculated such that a sufficient amount of vacuum can begenerated by pulling the rigid members 74 in opposite directions(thereby expanding the bag). FIG. 14 is a perspective view of the system70, showing one side of the bag 72 with rigid member 74 and pull tab 76,and a connection member 78 attached to one end of the bag 72, configuredfor releasable attachment to connection tube 30. FIG. 15 illustrates alengthwise cross-sectional view of the disposable bag 72 in a collapsedstate prior to initiating drainage (i.e., prior to imparting a negativepressure to the system 70). FIG. 16 illustrates a lengthwisecross-sectional view of the disposable bag 72 in an expanded state,following a pulling force being applied to the pull tabs 76 (i.e., thepull tabs 76 are pulled in opposite directions). As with the system 50described above, system 70 can be operated as both active (i.e.,utilizing only a pulling force to expand the bag 72) and passive (i.e.,providing an initial pulling force to begin fluid flow and subsequentlypositioning the bag 72 below the level of fluid to be drained).

FIGS. 17-18 illustrate another embodiment of a pump utilized in acorporeal drainage system. In this embodiment, the pump is in the formof a small hand pump (which may be made small enough in size to beconsidered a “finger pump”) with a rebound area that is able to generatea large suction with a relatively small force. FIG. 17A-C illustrateembodiments of a small hand pump having a bulbous configuration. In FIG.17A, the pump 80 includes a configuration with luer-type connectors atproximal and distal ends to facilitate attachment of the pump in-line toconnect a connection tube and fluid receptacle, a connection tube and animplanted catheter, etc. The pump 80 includes two unidirectional valves,one at the proximal end and one at the distal end, to provide theability of creating a negative pressure in a corporeal drainage system.The body 82 of the pump 80 can be made of a flexible material, such as,for example, silicone. FIGS. 17B and 17C illustrate two variations ofthe body 82 of the pump 80, FIG. 17B having a configuration in which thelargest diameter of the bulb body 84 is positioned nearer the proximalend than the distal end, and FIG. 17C having a symmetrical configurationin which the largest diameter of the bulb body 84 is approximatelyequidistant from the proximal and distal ends. FIG. 18 illustrates atubular-shaped hand pump 90, requiring a minimal force to begin fluidflow. To initiate fluid flow using hand pump 90, a user grasps betweenfingers (e.g., between the thumb and index finger) and squeezes one ormore times. In one embodiment, hand pump 90 has a length in the range ofapproximately 1 in. to approximately 6 in. and a diameter in the rangeof approximately 0.25 in. to approximately 2 in. While hand pumps 80 and90 are shown in particular configurations, it should be appreciated thatmany sizes and shapes are possible and would be within the scope of thisinvention.

The hand pumps 80 and 90 can be placed in-line into a system, connectingthe connection tube 30 to either a reusable container with a disposablebag therein, a disposable bottle, or a disposable bag (e.g., zero volumecollapsed bag), as described above. In one embodiment, the hand pump 90is incorporated into system 100, as illustrated in FIG. 19. A pair ofone-way check valves 92, 94 respectively connect the hand pump 90 to theconnection tube 30 and the fluid receptacle 102 (e.g., container,bottle, bag, etc.). In this embodiment, the hand pump 90 is includes abody made from a material that is transparent. Thus, by placing the handpump 90 in-line in system 100, the pump 90 also acts as a “drip chamber”so that the user is able to visually monitor the flow of fluid from thebodily cavity to the fluid receptacle 102. Operation of system 100includes first activating the hand pump 90 by squeezing the sidestogether and subsequently releasing one or more times (e.g., five or sixtimes), which creates a negative pressure in the connection tube 30 asair is transported through the one-way check valves 92, 94 in adirection toward the fluid receptacle 102 until fluid begins flowingtherein. Thereafter, as explained above in connection with a passivesiphoning process, the fluid receptacle 102 is dropped to a level belowthe bodily cavity being drained (e.g., placed on the floor). The minimalforce required to begin fluid flow in system 100 as described isadvantageous to the target user due to strength and stamina concernsdiscussed above. The relative small size of the system (especially inthe case that the system includes a zero volume collapsed bag)facilitates shipping and storage.

As discussed above, the corporeal drainage system may include aconnection system for easy, fast and secure connection between animplanted catheter and a connection tube as described herein (e.g.,connection tube 30). Particular connection systems for the corporealdrainage system described herein are disclosed in commonly owned U.S.Provisional Application No. 60/720,443, filed Sep. 26, 2005, entitled“Catheter Connection System,” the complete contents of which areexpressly incorporated by reference as if fully set forth herein. Oneexample of a corporeal drainage system incorporating a catheterconnection system is illustrated in FIG. 20, which shows corporealdrainage system 110 prior to the initiation of a drainage process,including fluid receptacle 112, pump 114, first fluid flow conduit 116,connecting the pump 14 to the fluid receptacle 112, second fluid flowconduit 118, and drainage line connector 120. A catheter connector 130is connected to an implanted catheter 140, the catheter connector 130and drainage line connector 120 being configured to fluidly connectsecond conduit 118 to catheter 140, as described more completely incommonly owned U.S. Provisional Application No. 60/720,443. To utilizethe corporeal drainage system 110, the connection between the catheterconnector 120 and drainage line connector 130 is first established,followed by activation of the system by priming (e.g., squeezing) thepump 114 one or more times to initiate fluid flow from a bodily cavity.The fluid receptacle 112 is either initially positioned below the cavityto be drained or is positioned below the cavity to be drained followingactivation of the system.

FIGS. 21-22 illustrate a connection system according to one embodiment.FIG. 21 shows a catheter connector 200 including a body 210 defining atapered feature 220 and flow apertures 230. A sealing element 240 isprovided to abut the tapered feature 220 to effectively seal the flowapertures 230. A retaining element 250 may be provided to resistmovement of the sealing element 240 toward a distal end 260 of the body210. FIG. 22 shows the catheter connector 200 coupled to a drainage lineconnector 270. The drainage line connector 270 includes a positioningsleeve 280 and an actuating member 290 so that when the drainage lineconnector 270 is connected to the catheter connector 200, the actuatingmember 290 deforms the sealing element 240 away from the tapered feature220 and allows fluid flow through a gap 225 there between.

FIGS. 23-24 illustrate another example of a connection system comprisinga sealing element positioned between at least two components, whereinthe components are coupled to one another by at least one hinge clip.The connection system includes a catheter connector 300 and a drainageline connector 310. The drainage line connector 310 comprises a drainbody 320 including hinge clips 330 pivotably affixed to the drain body320. Each of the hinge clips 330 include an engagement feature 332configured to engage a complimentary coupling feature 340 of thecatheter connector 300. As shown in FIG. 23, the catheter connector 300may include a plug body 350 that defines a tapered feature 360. In oneembodiment, the tapered feature 360 is formed separately from the plugbody 350. In such a configuration, tapered feature 360 may be affixed(e.g., adhesively bonded, ultrasonically welded, solvent welded, orotherwise affixed) to the plug body 350. In another embodiment, thetapered feature 360 may be formed integrally or monolithically with theplug body 350. A sealing element 370 may abut the tapered feature 360 toeffectively seal a bore 380 of the sealing plug body 350 at one end. Aretaining sleeve 390 may facilitate coupling of the deformable sealingelement 370 to the sealing plug body 350. Also, the retaining sleeve 390may extend beyond the deformable sealing element 370 and the taperedfeature 360 toward the drainage line connector 310. Such a configurationmay inhibit inadvertently deforming the deformable sealing element 370.The drainage line connector 310 may include an actuating member 395configured to deform the deformable sealing element 370 upon assembly ofthe drainage line connector 310 and the catheter connector 300 (see FIG.24). As shown in FIG. 24, the actuating member 395 may abut and deformthe sealing element 370 away from the tapered feature 360 to allow forfluid flow from the bore 380 of the catheter connector 300 to a bore 315of the drainage line connector 310.

FIGS. 25-26 illustrate yet another example of a connection systemcomprising a catheter connector 400 including a body 410 defining aprotruding feature 420, apertures 430, and a sealing element 440positioned between the protruding feature 420 and a closure element 450.The sealing element 440 forms a seal along a mating surface 460 definingan aperture through the closure element 450. A force F (e.g., generatedby an actuating member of a drainage line connector) may be applied toat least a portion of the sealing element 440 to deform the sealingelement 440 and allow fluid to flow through a gap 470 formed between thesealing element 440 and the closure element 450.

In another embodiment of a corporeal drainage system, the drainage lineconnector 130 is attached to a connection tube, such as connection tube30, which is connected to a fluid receptacle that also acts as a pumpfor the system (i.e., the initiator of negative pressure), such asillustrated in FIGS. 4-6, 7-13 and 14-16 and described above. Use ofsuch a system would begin with attachment of the drainage line connector130 to the catheter connector 120, followed by activation of the system,as described herein.

This invention has been described and specific examples of the inventionhave been portrayed. While the invention has been described in terms ofparticular variations and illustrative figures, those of ordinary skillin the art will recognize that the invention is not limited to thevariations or figures described. In addition, where methods and stepsdescribed above indicate certain events occurring in certain order,those of ordinary skill in the art will recognize that the ordering ofcertain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainof the steps may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.Therefore, to the extent there are variations of the invention, whichare within the spirit of the disclosure or equivalent to the inventionsfound in the claims, it is the intent that this patent will cover thosevariations as well. Finally, all publications and patent applicationscited in this specification are herein incorporated by reference intheir entirety as if each individual publication or patent applicationwere specifically and individually put forth herein.

What is claimed is:
 1. A method of draining fluid from a bodily cavity,comprising: providing a corporeal drainage system including a connectiontube and a fluid receptacle having only one opening to an interiorthereof, the opening in fluid communication with the connection tube,the fluid receptacle having an initial rest state in a fully orapproximately fully collapsed configuration before any force is applied;creating a negative pressure by transitioning the fluid receptacle fromthe collapsed configuration to an expanded configuration; and drawingfluid from the bodily cavity into the connection tube.
 2. The methodaccording to claim 1, further comprising placing the fluid receptacle ata level below the bodily cavity.
 3. The method according to claim 1,wherein creating a negative pressure includes pulling two opposing sidesof the fluid receptacle away from one another.
 4. The method accordingto claim 1, wherein the corporeal drainage system further includes anactivation member, the creating a negative pressure comprisingactivating the activation member.
 5. The method according to claim 4,wherein the activation member comprises a first locking member and asecond locking member releasably coupled to the first locking member inthe collapsed configuration, the creating a negative pressure comprisinguncoupling the first and second locking members.
 6. The method accordingto claim 1, wherein the fluid receptacle comprises flexible side walls,the method further comprising connecting the connection tube to thefluid receptacle on a side edge of the flexible side walls.